Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs

A retrospective observational study of FDA and NCCN reports found that cancer drug indications that received accelerated approval often remained on formal FDA approved drug labelling and continued to be recommended in clinical guidelines several years after post-approval trials showed no improvement in the primary efficacy end point. Clinical guidelines should better align with the results of post-approval trials of cancer drugs that received accelerated approval.